Cleaning, Sanitation and Contamination Prevention – Equipment Cleaning

This convenient instructor-led training focuses on equipment cleaning of dietary supplement facilities in accordance with 21 CFR 111. This comprehensive training delivers extensive industry experience and real-world exercises with remote networking opportunities to ask questions and learn best practices from colleagues facing similar issues.

At the end of the course, you will know and understand:

• The requirements of equipment cleaning and sanitizing
• How to convert regulatory requirements into a real-world application for use in writing compliant protocols to prevent product contamination
• The steps and documentation to execute equipment cleaning protocols and final reports per FDA regulation
• What standard operating procedures are needed for your equipment cleaning qualifications to ensure compliance with FDA regulations

Anyone from:

• Management
• Manufacturing
• Sanitation supervisor
• Quality control/assurance
• Packaging
• Marketing
• Laboratory operations
• Auditing
• Suppliers and distributors
• Regulatory affairs

Course instructors will be selected from the following:

Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.

Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.